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Sublingual Sufentanil More Effective Than IV Morphine in Phase III Trial
Additional clinical results for the Sufentanil NanoTab patient-controlled analgesia (PCA) system are being presented at the American Society of Regional Anesthesia and Pain Medicine (ASRA) spring meeting, held May 2–5, 2013, in Boston, Massachusetts.
Sublingual Sufentanil NanoTabs are delivered via an investigational preprogrammed, noninvasive, handheld system that allows postoperative patients to self-dose their moderate-to-severe acute pain in the hospital setting.
New analyses from a phase III comparison trial of the NanoTab system and intravenous (IV) PCA with morphine showed that sufentanil delivered via the NanoTab system achieved a significantly greater reduction in pain intensity during the first 4 hours after starting treatment than IV PCA morphine (P
In addition, fewer patients throughout the study experienced oxygen desaturation events below 95% in the group treated with the Sufentanil NanoTab PCA system than in the IV PCA morphine group (P = 0.028). Oxygen saturation is a measure of a patient’s respiratory function and can be affected negatively by opioids. A decrease in oxygen saturation may lead to respiratory depression.
Regulatory submission is expected in the third quarter of 2013.
Source: AcelRx Pharmaceuticals; May 2, 2013.